Summary:
Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on review of the Clinical Laboratory Improvement Amendment (CLIA) application (Form CMS-116), patient test report, and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at 11:24 am on 11 /14/2023, the laboratory failed to indicate the name and address of the testing facility for one out of one patient test report reviewed from October 2023. The findings include: 1. Patient identifier A had fetal rupture of membrane testing performed on 10 /20/2023. 2. The CLIA application listed the name and address of the facility as Pella Regional Health Center Ottumwa Medical Clinic, 920 North Quincy Avenue, Ottumwa, IA 52501. 3. The test report for Patient identifier A recorded the name and address of the testing facility as Pella Regional Health Center Laboratory, 404 Jefferson Street, Pella, IA 50219. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --